Key Dates

Related Announcements

None

Issued by

National Center for Advancing Translational Sciences (NCATS)

Purpose

Background

The mission of the National Center for Advancing Translational Sciences (NCATS) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and dissemination of effective medical/behavioral interventions diagnostics and therapeutics across a wide range of human diseases and conditions. The NCATS Clinical and Translational Science Awards (CTSA) Program supports a consortium of CTSAs located at medical research institutions across the Nation (see https://ncats.nih.gov/ctsa/about). The focus of this consortium is to foster high-quality, collaborative translational science, essential to meeting the NCATS mission. This is performed through innovation in translational science, workforce development, infrastructure support, trans-consortium collaboration, and community engagement. 

An evolving trend in clinical trial (https://grants.nih.gov/policy/clinical-trials/definition.htm) design has been for their decentralization or their ability to be performed in part, or entirely away from traditional medical research institutions. Decentralized clinical trials (DCTs) have the potential to improve the efficiency and speed of implementation for interventions, treatments, and/or diagnostics to be brought to individuals and populations. Decentralized or hybrid clinical trials are the common terms for these types of trial designs. To enable their proportionately or entirely offsite designs, they utilize community providers and technology to implement, deliver data (e.g., regarding safety, efficacy), or relay feedback about participant status. Indeed, this is performed through a combination of software, digital health technologies (including in-home objective measures, wearables, etc.), telemedicine, community healthcare providers, local pharmacies, mobile research units, point-of-care diagnostics, and more. They offer opportunities to: decrease burden(s) to trial participants (e.g., distance, monetary, logistical, emotional); improve recruitment and retention enabling medical/health interventions to succeed or fail faster without early termination; and deliver more real world, generalizable clinical research findings from broader participation. However, challenges do exist to accelerating this clinical research approach. 

Overcoming these challenges is in line with the mission of NCATS as well as the CTSA Program. To advance the ability to perform decentralized or hybrid trials, much is needed, including: gaining a deeper understanding of the interplay of the clinical and translational processes inherent to offsite clinical trials such as clinical workflow integration and patient reporting; robust community engagement and human-centered design; bespoke resources that could be leveraged to rapidly implement and operationalize; collaborations and partnerships developed; continued development, validation and implementation of the enabling tools such as informatics systems, data integration platforms, digital health technologies (e.g., those that use computing platforms, connectivity, software or sensors for remote data collection) including machine learning or artificial intelligence to integrate disparate data types and linking outcomes, and ensuring that data from DCTs can be used by regulatory bodies and will be adopted by clinicians.  

Information Requested

This RFI invites stakeholders throughout the scientific research, advocacy, clinical practice, industry, patient and lay communities, including the general public, to comment on how DCTs may be designed to be more effective, efficient and equitable to bring more interventions to all people, faster. In particular, comments are sought on ways to enable participants from 1) diverse backgrounds, that includes, but is not limited to race, ethnicity, socioeconomic status, background, gender, and mental or physical ability; and 2) those who are underserved, used in the context of Health Disparities related to population-based health. A population is defined by the Minority Health and Health Disparities Research and Education Act of 2000 (Public Law 106-525) as a health disparity or underserved population if there is a significant disparity in the overall rate of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population, to participate in clinical trials. These comments can be with respect to the CTSAs and/or the broader academic medical research enterprise. 

Possible areas for comment include, but are not limited to:

Application of research methods in decentralized clinical trials (DCTs)

• Demonstrating how DCTs advance and accelerate the implementation of clinical trials
• Developing novel clinical trial research methods for DCTs
• Improving translational processes and workflows for study participants in DCTs
• Key factors to consider when designing and deploying a DCT

Resources, Infrastructure, and Enabling Technologies

• Identifying available resources, tools, or technologies used, or useful, for DCTs and technological needs for the future as well as common operational challenges in deploying and running DCTs
• Measuring the financial burden versus benefit of DCTs and considering the areas of clinical research where they would have the most impact
• Identifying resources to collect and validate digital health technology-derived data for its use in DCTs and subsequent linking to other sources (e.g., reliable public health data sources)
• Identifying resources, tools, or technologies which may be utilized to collect and analyze large data sets during a DCT as well as post-approval indications utilizing Real World Evidence derived from Real World Data post-approval for Real-World Data and Real-World Evidence

Community Engagement 

• Identifying the needs of participants, in particular those whom traditionally experienced health disparities or in an underserved population, to participate in DCTs
• Establishing support for the identified needs of participants to be engaged in DCTs 
• Facilitating authentic and meaningful, community driven engagement (e.g., embedding clinical trials into community health care settings) 

Workforce Development

• Identifying and developing a clinical research workforce with knowledge, skills, and abilities to administer a DCT
• Understanding the social and/or cultural nuances of communities
• Establishing knowledge and procedures to co-design studies with communities

Partnerships and/or Collaborations

• Identifying partnerships and/or collaborations essential for DCTs to be successful (inclusive of government agencies, industry, non-profit organizations, academia, etc.)
• Developing partnerships and/or collaborations to enhance engagement with diverse or and/or underserved participants for DCTs
• Establishing meaningful and efficient integration of community health hospitals, pharmacies, and community providers for DCTs
• Identifying partnerships and/or collaborations needed for the dissemination and sustainability of identified technologies/platforms

Study Participation and Adherence

• Developing the methods, tools, resources, and platforms to efficiently, safely, and securely screen, consent, enroll and follow up with DCT research participants
• Identifying tools and resources to decrease the burden on the participants of clinical studies
• Identifying tools and resources to match the preferred method for targeted populations and to provide support throughout the process (e.g., concierge/help desk services)
• Employing strategies to provide and tailor ongoing research support and technologies to stimulate participation by diverse and/or underserved populations in research

Data integration, quality, accessibility, and reproducibility

• Maintaining data consistency and quality relative to digital health technologies and/or Bring-Your-Own-Device (BYOD) approaches in the context of a DCT
• Monitoring and acting on DCT data quality in real-time 
• Providing study participants access to their own data and study information post-hoc or in real-time and granting access to deidentified data for the research community
• Analyzing, and reporting, disparate data generated from both the centralized and DCT results

Privacy and Regulatory Considerations

• Designing, conducting, and documenting DCTs to ensure compliance with regulatory bodies
• Fostering outreach methods for participant populations to be assured of their privacy
• Ensuring engagement by study participants to rigorously adhere to the protocols, security, safety measures, and regulatory requirements

The above scientific areas and issues of interest are examples. Respondents are welcome to note and provide comments on other areas and issues they deem important or essential to consider.

How to submit

Responses to this RFI must be submitted electronically to the following NIH RFI submission link (https://rfi.grants.nih.gov/?s=63d1730a815c8d599f0af604). Responses must be received by 11:59 p.m. (Eastern Standard Time) on May 12, 2023. Responses to this RFI are voluntary. Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. If information you provide is available on a website or in published material, please provide appropriate links. No forms are required for submission. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder. The Government will use the information submitted in response to this RFI at its discretion. The Government reserves the right to use any submitted information on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Christopher M Hartshorn, Ph.D.
National Center for Advancing Translational Sciences
Telephone: 301-402-0264
Email: christopher.hartshorn@nih.gov

Erica Rosemond, Ph.D.
National Center for Advancing Translational Sciences
Telephone: 301-594-8927
Email: rosemonde@mail.nih.gov